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Drug company (FDA labeler)

Torrent Pharma, Inc.

NDC labeler code: 13668

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
2Products (NDC)
1FDA applications
10Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
January 19, 2022ANDA214035 Ranolazine
RANOLAZINE		Vkt Pharma

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2025

  1. May 27, 2025 · Class II · Completed · D-0455-2025 · Fluoxetine

    CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

    Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30

  2. May 27, 2025 · Class II · Completed · D-0456-2025 · Fluoxetine

    CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

    Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Cart

2022

  1. April 11, 2022 · Class II · Terminated · D-0852-2022 · Pantoprazole sodium

    CGMP deviations: tablets cracking

    Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, N

2021

  1. December 2, 2021 · Class II · Terminated · D-0365-2022 · Carbamazepine

    Failed Dissolution Specifications

    Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.

  2. March 15, 2021 · Class II · Terminated · D-0584-2021 · Darifenacin

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30

  3. March 15, 2021 · Class II · Terminated · D-0583-2021 · Darifenacin

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30

2020

  1. November 25, 2020 · Class I · Terminated · D-0166-2021 · Anagrelide

    Failed Dissolution Specifications

    Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

  2. May 11, 2020 · Class II · Terminated · D-1317-2020 · Carbamazepine

    Failed Dissolution Specifications

    Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-2

2019

  1. September 6, 2019 · Class II · Terminated · D-1862-2019 · Anagrelide

    Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.

    Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.

2018

  1. September 11, 2018 · Class II · Terminated · D-1204-2018 · Lamotrigine

    Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

    Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →